This approval allows full commercial launch for Andexxa, which was previously launched under an Early Supply Program with Generation 1 product. The new Generation 2 manufacturing process will enable it to scale up production and stock hospitals nationwide, according to the company.

Andexxa originally received regulatory approval in May 2018 under the FDA’s Accelerated Approval pathway as the first antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Andexxa’s approval was based on data from two 2 phase 3 studies which evaluated the safety and efficacy in reversing anticoagulant activity of rivaroxaban and apixaban in health volunteers. The studies showed Andexxa rapidly and significantly reversed anti-Factor Xa activity. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban, according to the data.2

Additionally, data from 185 patients showed that Andexxa rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus and sustained reversal when followed by a 120-minute infusion, with a median decrease from baseline of 90% for rivaroxaban and 93% for apixaban.2

“It is clear from the response to the Andexxa Early Supply Program that there is a significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland, president and CEO of Portola, said in a statement.1 “We are pleased to now be able to stock hospitals nationwide and serve all patients in the US who could benefit from the potential life-saving impact of Andexxa.”

In 2017, there were approximately 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding in the United States, according to the release.

In patients receiving Andexxa, the most common adverse reactions were urinary tract infections and pneumonia. Infusion-related reactions were the most commonly reported adverse effects in healthy trial volunteers.